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Gilead to supply lenacapavir at cost to 2 million people

over

three years

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Global Fund prioritizes access based on HIV incidence,

focuses

on sub-Saharan Africa

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Gilead CEO hopeful of future US funding for global HIV

programs

By Deena Beasley and Jennifer Rigby

July 9 (Reuters) - Gilead Sciences ( GILD ) and the

Global Fund to Fight AIDS, Tuberculosis and Malaria said on

Wednesday they had finalized plans to supply a long-acting HIV

prevention drug to low-income countries, despite the absence of

funding from a key U.S. initiative aimed at addressing the

global HIV/AIDS epidemic.

Under the agreement, Gilead said it will supply, at cost,

enough doses to reach up to 2 million people over three years in

countries supported by the Global Fund. Both parties said price

terms are confidential, and the Global Fund declined to comment

further on how many doses would be ordered immediately.

The U.S. Food and Drug Administration last month approved

Gilead's lenacapavir, a twice-yearly injection, for preventing

HIV infection in adults and adolescents. The World Health

Organization and other regulators are currently reviewing it.

Last year, Gilead signed royalty-free deals allowing six

generic drugmakers to make and sell low-cost versions of the

drug in 120 low- and middle-income countries, but those supplies

will take time to get up and running.

Some AIDS experts have said the new drug could help end the

44-year-old epidemic that infects 1.3 million people a year and

is estimated by the World Health Organization to have killed

more than 42 million.

The Global Fund said it will prioritize access based on HIV

incidence and prevention strategies, including countries in

sub-Saharan Africa that have expressed strong interest - notably

South Africa, which will be among the first to roll out the drug

among around 10 other nations.

The partners aim to have the first delivery reach at least

one African country by the end of this year.

"For the first time, a tool to prevent HIV infection is

coming available in low and middle-income countries at the same

time as in high-income countries," Peter Sands, executive

director of the Global Fund, said in an interview with Reuters.

In the past, this has taken years, he added.

Gilead, the Global Fund and the United States President's

Emergency Plan for AIDS Relief had announced the plan in

December.

However, the administration of U.S. President Donald Trump,

who took office in January, has pulled back on PEPFAR funding,

limiting global HIV prevention programs to pregnant and

breastfeeding women.

In response to questions about the impact of the cuts on

HIV programs worldwide, a U.S. State Department spokesperson

told Reuters: "PEPFAR-funded programs that deliver HIV care and

treatment or prevention of mother-to-child transmission services

are operational... All other PEPFAR-funded services are

currently being reviewed." They did not respond to questions on

lenacapavir specifically.

Gilead CEO Daniel O'Day said he is still hopeful that U.S.

aid spending to fight the epidemic will resume.

"We want to be spending less over time on HIV because the

incidence is lower ... we should put resources toward things

that actually reduce the burden of disease over time."

Gilead is also working with middle-income countries, many of

which are in Latin America, to make lenacapavir accessible as

soon as possible, he said.

The drug, which has the brand name Yeztugo, has an annual

list price in the United States of $28,218.

The Children's Investment Fund Foundation pledged $150

million to the Global Fund earlier this year, including money

for the lenacapavir initiative. Sands said more donors were also

needed.